Associate Director, Clinical Manufacturing Operations

Company Description

Axolabs specialises in a new class of drugs whose active ingredients are chemically derived from DNA or RNA. They are called oligonucleotide or nucleic acid therapeutics. We use our many years of expertise to help our clients make them a success. Some of these drugs have already been approved and are being used successfully against diseases that were previously untreatable in some cases. New drugs from this class are added every year.

We believe in Science for a Safer World and are currently seeking candidates who are up for the challenge of operating in a high-growth, purpose-driven organization. LGC Axolabs is located in Petaluma, US, Kulmbach and Berlin, Germany.

Job Description

• Oversee the plant operations facility and team by coordinating and monitoring activities
• Provide necessary program direction (tracking and reporting tools) for planning, organizing, developing, and integrating projects across multiple functional areas
• Mentor and manage a growing team of supervisors, chemists, and technicians.
• Writes and/or reviews MBR's, SOP's, and other technical documents.
• Ensures operations are in compliance with all Regulatory, EHS, and cGMP quality systems that assure proper design, monitoring, and control of manufacturing processes and facilities.
• Manages the capex budget and raw material needs, production schedules, finished product inventories and logistics of shipments.
• Evaluate and implement new technologies as needed.
• Reporting of KPIs, operational metrics and project updates to SLT.
• Act as a change agent to implement necessary manufacturing suite improvements as dictated by business needs.

Qualifications

• Bachelors of Science (BS) in Chemical Engineering, Organic Chemistry, Process Chemistry or Physical Chemistry and a minimum of 10 years of experience within Pharmaceutical or CDMO industries including substantial GMP experience.
• In-depth understanding and application of cGMP principles, practices, and standards.
• Prior experience and a broad range of knowledge in Quality and Compliance in the Manufacturing of APIs in a regulated environment.
• Some knowledge in Nucleic Acid Therapeutic regulations and guidance preferred.
• 5+ years management level experience with ability to develop staff.
• Ability to influence stakeholders and drive decision-making.
• Experience in MasterControl eQMS and eBR is a plus.
• Experience in Unicorn, Opti-Dry, Rockwell Studio is a plus.
• Experience in small-molecule, peptide, oligonucleotide Kilo-lab or pilot plant operations.
• Knowledge of chemical engineering principles including reaction kinetics, reactor design, chemical thermodynamics, process modeling, heat, and mass transport
• Experience of downstream process including, ultrafiltration and diafiltration, chromatography and final polishing steps.
• Experience of lyophilization / freeze-drying.
• Understanding and experience in Solid-Phase Oligonucleotide Synthesis (SPOS) based on phosphoramidite chemistry is a plus.
• Understanding and experience in chemical process scale-up and manufacturing of pharmaceuticals
• Solid understanding of practices required to conform to health agency guidelines that control the authorization and licensing of pharmaceutical products (GMP).

Additional Information

What we offer (US based-employees):

• Competitive compensation with strong bonus program
• Comprehensive medical, dental, and vision benefits for employees and dependents
• FSA/HSA Pre-tax savings plans for health care, childcare, and elder care
• Deductible Buffer Insurance and Critical Illness Insurance
• 401(k) retirement plan with matching employer contribution
• Company-paid short- and long- term disability, life insurance, and employee assistance program
• Flexible work options- 8, 10 and 12 hour shifts available with option of day, swing and night shifts.
• Pet Insurance for our furry friends
• Enhanced Parental leave of 8 additional weeks
• PTO that begins immediately
• Full week paid off during the holidays
• Town Hall monthly meeting onsite/virtual, Cheer program where employees are recognized for outstanding work, Companywide social events, frequent catered lunches and much more!

The typical pay range for this role is:

Minimum: $ 127,500 /Yearly

Maximum: $ 212,500 /Yearly 

This range represents the low and high end of the anticipated salary range for the California -based position.  The actual base salary will depend on several factors such as: experience, skills, and location.

ABOUT LGC: 

LGC is a leading, global life science tools company, providing mission-critical components and solutions into high